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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K063401
Device Name BANANA RIBBED
Applicant
MEDTECH PRODUCTS LTD.
5876 155TH AVE. S.E.
BELLEVUE,  WA  98006
Applicant Contact RAVI REDDY
Correspondent
MEDTECH PRODUCTS LTD.
5876 155TH AVE. S.E.
BELLEVUE,  WA  98006
Correspondent Contact RAVI REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/09/2006
Decision Date 03/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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